Skip to content

An application documentation to study the clinical effects and the tolerability of the immunoBON FSMP in patients with allergic rhinoconcunctivitis

An application documentation to study the clinical effects and the tolerability of the immunoBON FSMP in patients with allergic rhinoconcunctivitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032757
Enrollment
60
Registered
2023-09-28
Start date
2020-11-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinoconjunctivitis with/without asthma in cat dander/dust mite/pollen allergic patients.

Interventions

Group 1: 3-month intake of the immunoBON/holo-BLG lozenge

Sponsors

Bencard Allergy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to No maximum

Inclusion criteria

Inclusion criteria: IgE-mediated allergic rhinoconjunctivitis with or without asthma against birch pollen OR house dust mites (HSM) and/or animal epithelia for at least one year (all degrees of severity), confirmed by prick test or by means of corresponding IgE detection in serum (co-sensitizations without clinical relevance are allowed). - At the time of inclusion, no indication for allergen-specific immunotherapy (AIT) given or AIT not desired by the patient. - Age from 3 years under the condition that the tablets can be reliably sucked - Written consent for data collection

Exclusion criteria

Exclusion criteria: - Intolerance of milk protein - Diseases of the gastrointestinal tract (e.g. eosinophilic esophagitis) and/or serious diseases which, in the opinion of the investigator, constitute a contraindication to the use of immunoBON - Medical conditions associated with an increased risk of aspiration - Ongoing performance of AIT - Completed AIT for the dominant allergen to be documented within the last 12 months. - Lactose intolerance to an extent which, in the opinion of the attending physician, constitutes a contraindication to the use of immunoBON

Design outcomes

Primary

MeasureTime frame
Rhinoconjunctivitis Score, Combined symptom and medication score (CSMS)

Secondary

MeasureTime frame
Tolerability and Adherence

Countries

Germany

Contacts

Public ContactRalph Mösges

ClinCompetence Cologne GmbH

ralph.moesges@clincompetence.de+49 221 7161 330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026